MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-01-18 for SOFT-PASS ECHOTIP EMBRYO TRANSFER CATHETER SET K-J-SPPE-681710-ET manufactured by Cook Inc.
[97709881]
(b)(4). The event is currently under investigation. A follow up report will be submitted upon receipt of additional information or completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[97709882]
The customer reported that one normal female blastocyst was thawed in preparation for the embryo transfer procedure. Prior to the embryo transfer procedure a trial transfer was performed using the cook soft-pass echotip embryo transfer catheter set. During the trial transfer the metal of the echo-tip soft-pass embryo transfer catheter was noted to be missing and the transabdominal ultrasound showed a small echogenic area within the lower uterine segment consistent with the metal of the echo-tip catheter. The embryo transfer procedure was cancelled and on the following day a hysteroscopic removal of the metal was successfully done. No further information is available at this time regarding the patient or procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-00016 |
| MDR Report Key | 7203571 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-01-18 |
| Date of Report | 2018-04-20 |
| Date of Event | 2017-12-18 |
| Date Mfgr Received | 2018-04-19 |
| Device Manufacturer Date | 2017-09-06 |
| Date Added to Maude | 2018-01-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOFT-PASS ECHOTIP EMBRYO TRANSFER CATHETER SET |
| Generic Name | MQF CATHETER, ASSISTED REPRODUCTION |
| Product Code | MQF |
| Date Received | 2018-01-18 |
| Catalog Number | K-J-SPPE-681710-ET |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-01-18 |